We are currently seeking a highly skilled and dedicated Quality Engineering Specialist for a 6-month contract, starting asap.
Key Responsibilities:
- Holds all quality related responsibilities for daily qualification activities on technical facilities, equipment and systems
- Supports the development, reviews and releases qualification documents.
- Approves applicable qualification documents
- Assesses and approves change requests with regard to their relevance to the qualified state condition and ensures this supports and approves quality risk analysis (e.g. GMP-FMEA)
- Ensures that deviations are appropriately investigated and addressed in deviation reports processed in deviation reports
- QA activities follow legislation, authority and customer expectations.
- Informs the Group Manager QA Qualification about relevant developments and trend
- Actively supports the formulation and further development of qualification strategies and continues to training accordingly
- Supports internal audits in accordance with the internal audit plan, at customer audits and official inspections as QA representative (SME)
Key Requirements:
- Experience in biotechnology or pharmaceutical environment
- Experience as QA Qualification
- Knowledge on FAT/SAT/IQ/OQ/PQ
- You are proactive, with good communication skills and are able to work in a multidisciplinary team towards a common goal.
- You are fluent in English (spoken and written)
Beneficial skills:
- Experience in risk analysis
- German speaking
- Knowledge of SAP, DMS and TrackWise
- Independent/pro active
- Home office 40% possible
For further information about this position, please apply with your CV
*Please note, only those with the right to work in Switzerland can apply!
